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Efficacy of High Flow Therapy in COPD At Home

Efficacy of High Flow Therapy in COPD At Home

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02230020
Acronym
EHFT
Enrollment
8
Registered
2014-09-03
Start date
2013-08-15
Completion date
2015-12-13
Last updated
2017-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Brief summary

Preliminary data show that in COPD patients, HFT substantially decreases ventilatory demand during sleep. The central hypothesis of this proposal is that lowering ventilatory demand using nasal high-flow therapy during sleep will elevate lung function, reduce dyspnea on exertion and improve quality of life. Thus, this proposal aims will determine the effects HFT over time on 1) lung function; 2) dyspnea on exertion; and 3) quality of life.

Interventions

Sponsors

Johns Hopkins University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* 1\. Consenting adults over the age of 18 with COPD

Exclusion criteria

* 1\. Apnea Hypopnea Index\>15 events/hr 2. Use of Non-invasive positive pressure ventilation (CPAP + Bilevel) 3. Severe bilateral nasal obstruction (apparent mouth breathing at rest) 4. Documented clinical cardiovascular disease, as defined below: 1. myocardial infarction in past 3 months 2. revascularization procedure in past 3 months 3. implanted cardiac pacemaker or ICD 4. unstable arrhythmias 5. congestive heart failure with ejection fraction \< 40% 6. uncontrolled hypertension (BP \> 190/110) 5. History of end stage renal disease (on dialysis) 6. History of end stage liver disease, such as: <!-- --> 1. Jaundice 2. ascites 3. history of recurrent gastrointestinal bleeding 4. transjugular intrahepatic portosystemic shunt (TIPS) ; 7. Transportation industry worker (commercial truck or bus drivers, airline pilots) 8. Known pregnancy (by self report) 9. Known coagulopathy or anticoagulant use (e.g. coumadin) other than aspirin. 10. Do you take medications for any of the following reasons: <!-- --> 1. Pain control (besides NSAIDs) 2. Sleep medication 3. Benzodiazepines 4. Methadone

Design outcomes

Primary

MeasureTime frameDescription
Lung FunctionBaseline and 1 monthSpirometry will be performed before and after each sleep study
Dyspnea scoreBaseline and 1 monthBorg scale score before and after each sleep study
Sleep qualityBaseline and 1 monthSleep architecture assessed from sleep studies
Quality of lifeBaseline and 1 monthSt Georges Respiratory Questionnaire Hopkins Sleep Survey MRC Breathlessness Scale UCSD Shortness of Breath

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026